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N Engl J Med. 2014 Sep 18;371(12):1091-9. doi: 10.1056/NEJMoa1406430. Epub 2014 Aug 31.

Ivabradine in stable coronary artery disease without clinical heart failure.

Collaborators (1299)

Fox K, Ferrari R, Ford I, Steg PG, Tardif JC, Tendera M, Ferrari R, Iglesias R, Zelveian PA, Freedman B, Huber K, Vanoverschelde JL, Machado Cesar LA, Gotcheva N, L'Allier P, Hu DY, Lau CP, Bergovec M, Hradec J, Clemmensen P, Hildebrandt P, Eha J, Laine M, Danchin N, Kedev S, Chumburidze V, Münzel T, Vardas P, Borbola J, Kasliwal R, Crean P, Tavazzi L, Seisembekov TZ, Seung KB, Erglis A, Laucevicius A, Ali R, Alexanderson E, Atar D, Sy R, Rynkiewicz A, Gomes R, Macarie C, Mareev VY, Karpov YA, Ostojic MC, Koh TH, Murin J, Rakovec P, Sareli P, Macaya de Miguel C, Dellborg M, Lüscher T, Chiang CE, Sritara P, van Gilst WH, Jukema JW, Ergene O, Parkhomenko A, Hall A, Kuster F, Pham NV, Thygesen K, Frenneaux M, Jondeau G, Mosterd A, Camm J, Murray G, Dargie H, Kjekshus J, Maggioni AP, Robertson M, Lloyd S, Iglesias R, Ahaud Guerrero RA, Allall OA, Amuchastegui M, Bluro IM, Bustamante Labarta GF, Caccavo A, Cartasegna LR, Costamagna OJ, Cuello JL, Cuneo CA, Fuentealba VJ, Covelli G, García Duran RO, Garofalo PE, Garrido M, Gómez Villamajo O, Gonzalez MA, Guzman LA, Hershson AR, Hominal MA, Hrabar AD, Jure HO, Lobo Marquez LL, Luciardi HL, Luquez HA, Mackinnon IJ, Manuale OD, Marino JC, Milei J, Montana OR, Perna ER, Porcile R, Prado AD, Rodenas PM, Rodríguez MA, Ronderos RE, Sala JM, Salmón Blumberg E, Sánchez AS, Sanchez RA, Sassone SA, Schiavi LB, Schygiel PO, Sinisi VA, Trivi MS, Varini SD, Vensentini N, Vico ML, Vita NA, Zaidman CJ, Zelveian P, Aleksanyan A, Drambyan M, Hayrapetyan H, Kocharyan L, Piruzyan A, Sisakyan H, Ter Grigoryan V, Freedman SB, Alford K, Allada C, Arya M, Barron G, Benson M, Bloch M, Colquhoun D, Cross D, Dart A, Eccleston D, Heddle W, Jayasinghe R, Playford D, Prior D, Rogers J, Singh B, Szto G, Huber K, Eber B, Hoenig S, Leisch F, Pieske B, Vanoverschelde JL, Delforge M, Hollanders G, Kefer J, Leeman J, Marechal P, Missault L, Troisfontaines P, Van Cleemput J, Vervoort G, Vrolix M, Machado Cesar LA, de Albuquerque DC, Ardito WR, Aziz JL, Botelho RV, Braga JC, Braile MC, Cardoso JN, Castro FF, Correa Filho H, de Camargo Carvalho AC, de Oliveira JV, Barbosa EC, Da Silva PR, Faludi AA, Neto JR, Farsky PS, Feitosa G, Finimundi HC, Rosa E, Fonseca AG, Hernandes ME, Índio do Brasil CK, Jorge JC, Kormann A, Leaes PE, Maia LN, Maneti ER, Markman B, Montenegro ST, Neuenschwander FC, Pelloso E, Precoma DB, Reis G, dos Santos FR, Rossi PR, Saad JA, de Paiva MS, Saporito WF, Saraiva JF, Sebba WK, Smith P, Soares Fichino MZ, Sobral Sousa AC, Zimmerman SL, Gotcheva N, Arnaudova Z, Baycheva V, Benov H, Chobanska P, Chompalova B, Denchev S, Georgieva Z, Goshev E, Gotchev D, Goudev A, Grigorov M, Guenova D, Hergeldjieva V, Ivanova P, Lazov P, Mihov A, Mihov L, Milanova M, Mileva A, Mincheva V, Pencheva G, Petranov S, Popov A, Raev D, Runev N, Shehova N, Sirakova V, Stoikov A, Taseva T, Tisheva S, Tokmakova M, Tumbev H, Tzekova M, L'Allier PL, Abramson B, Bailey G, Baird M, Beaudry P, Berlingieri J, Boucher P, Bourgeois R, Chan YK, Chehayeb R, Cieza T, Constance C, Della Siega A, Dion D, Hess A, Hill L, Huynh T, Klinke P, Kouz S, Labonté R, Lainesse A, Lepage S, Lonn E, Ma P, Maranda C, Mymin D, Nawaz S, O'Keefe D, O'Mahony M, Poirier P, Radhakrishnan S, Sabbah E, Sabe-Affaki G, Savard D, Talbot P, Tremblay B, Yao L, Hu DY, Bai F, Chen JC, Chen SL, Chen XP, Chen YD, Cheng XS, Fu GS, Fu L, Ge JB, Gu SM, Guo T, Guo Y, He SH, Jiang B, Ke YN, Li AH, Li H, Li HM, Li HW, Li L, Li WM, Li XD, Li XY, Li ZQ, Ling F, Luo M, Ma CS, Ma GS, Ma JL, Miao PZ, Qi XY, Shou XL, Song ZY, Sun YX, Wang B, Wang HC, Wang JA, Wang JF, Wang ZR, Wei M, Wu ZG, Xie Q, Xu DL, Xu B, Yang CJ, Yang K, Yang P, Yao H, Yuan ZY, Zhang F, Zhang FC, Zhang SY, Zhang Z, Zhao RP, Zheng HC, Zheng ZQ, Zhou XC, Zhu JH, Bergovec M, Bagatin J, Bernat R, Buljevic B, Matasic R, Mavric Z, Milicevic G, Milicic D, Persic V, Pocanic D, Raguz M, Raos V, Samardzic P, Steiner R, Hradec J, Alan D, Bouchal P, Cepelak M, Cermak O, Danczik J, Dedek V, Fabik L, Frana P, Galuszka J, Golan L, Homza M, Houra M, Kaislerova M, Karel I, Kopeckova I, Kos P, Krejcova H, Kuchar L, Kunc M, Kyzekova J, Linhart A, Marcinek G, Mikus M, Monhart Z, Mrozek V, Naplava R, Nechvatal L, Opocensky M, Siegelova J, Sipula D, Sochor K, Spinar J, Stipal R, Sulda M, Vencour D, Vesely J, Vodnansky P, Vymetal P, Zajicek P, Zidkova E, Hildebrandt P, Clemmensen P, Akrawi F, Davidsen F, Heitmann M, Jensen JM, Jeppesen J, Johansen PB, Larsen J, May O, Melchior T, Nielsen T, Nørgaard BL, Ralfkiær N, Raymond I, Rickers H, Roseva-Nielsen N, Sjøl A, Skagen K, Wiggers H, Eha J, Alt I, Arbeiter K, Aug L, Averina O, Kaik J, Laane E, Lanno R, Loogna I, Randvee L, Reimand M, Rosenthal A, Soots M, Uuekula S, Vahula V, Valter I, Viigimaa M, Laine M, Strandberg TE, Strandberg A, Danchin N, Boudhane A, Bourdon A, Bouvier JM, Chati Z, Cottin Y, Davy JM, Fournier PY, Gosse P, Guillot JP, Mann H, Mansourati J, Martelet M, Ovize M, Roudaut R, Roynard JL, Thisse JY, Chumburidze V, Chapidze G, Khintibidze I, Shaburishvili T, Paposhvili K, Gochitashvili D, Melia A, Klimiashvili Z, Chapidze G, Muenzel T, Appel KF, Baar M, Bauknecht K, Beermann J, Bergmann P, Boehm M, Bosch R, Degtyareva E, Drexler M, Droese K, Felix S, Huegl B, Ince H, Jeserich M, Jahnke N, Janssen S, Kleinecke Pohl U, Kleinertz K, Kokott N, Krosse B, Kuehne U, Lappo M, Meissner G, Nienaber C, Proskynitopoulos N, Salbach P, Schaefer A, Schenkenberger I, Schmidt E, Schoen N, Schreckenberg A, Schroeder T, Spengler U, Stangl V, Taggeselle J, Tschoepe C, Weissbrodt M, Winkelmann B, Wolde CH, Vardas P, Kallikazaros I, Karvounis H, Katsivas A, Lymberi S, Manolis A, Nanas J, Pyrgakis VN, Tziakas D, Lau CP, Lee K, Li SK, Tse HF, Yue CS, Borbola J, Andrassy G, Bartal G, Csapo K, Cziraki A, Czuriga I, Dezsi C, Edes I, Forster T, Gaszner B, Herczeg B, Horvath C, Kosa I, Lakatos F, Lippai J, Lupkovics G, Matoltsy A, Medvegy M, Merkely B, Nagy L, Noori E, Palinkas A, Regos L, Sereg M, Szasz G, Sziegl Z, Takacs J, Tomcsanyi J, Toth K, Vertes A, Zamolyi K, Zilahi Z, Kasliwal R, Bhuvaneshwaran JS, Dani S, Dhall A, Dhandayuthapani S, Gadkari M, Hiremath S, Jain P, Kahali D, Kumar N, Mardikar H, Patel T, Pinto B, Prasad G, Sandhu MS, Sethi S, Tavazzi L, Agrusta M, Antonicelli R, Antoniucci D, Barillà F, Bolognese L, Castriota F, De Matteis C, Di Biase M, Di Iorio C, Favretto G, Felis S, Fresco C, Frigiola A, Gavazzi A, Giannuzzi P, Guardigli G, Guarneri A, Ingrillì F, Ieva M, Liso A, Minneci C, Mos L, Paparoni S, Pelà MG, Perna B, Perna G, Potere F, Proietti G, Raisaro A, Riccioni G, Sanfilippo N, Sinicropi G, Tamburino C, Vassanelli C, Vitale C, Zipoli A, Crean P, Barton J, Crowley J, Harrington P, Maher V, McAdam B, Twomey K, Seisembekov T, Bekbossynova M, Imantaeva G, Kim V, Kozlova I, Kultaev M, Mussagalieva A, Yanina N, Zhussupova G, Seung KB, Ahn TH, Ahn Y, Chae JK, Chae IH, Han KR, Hong MK, Hur SH, Hwang JY, Kim JB, Kim HS, Kim SY, Kim MH, Kim DI, Kim DK, Lee SH, Lee SH, Lee JM, Lee BR, Lim DS, Oh SK, Park WJ, Park JS, Park JP, Park HS, Rha SW, Ryu KH, Tahk SJ, Yang JY, Erglis A, Gersamija A, Mintale I, Ozolina MA, Pontaga N, Rancane G, Rozkova N, Saulite-Kandevica D, Sime I, Strizko I, Laucevicius A, Anusauskiene J, Dailydkiene A, Kavoliuniene A, Kibarskis A, Kirkutis A, Maslauskaite-Voluckiene E, Naudziunas A, Petrulioniene Z, Rudys A, Sakalyte G, Slapikas R, Varoneckas G, Vasiliauskas DA, Kedev S, Petrov S, Poposka L, Anguseva T, Kovkaroski A, Donchovska S, Nastevska S, Ali RM, Abdul Manap H, Ismail O, Jaafar AH, Keat BC, Lee CY, Maskon O, Ng KH, Ong TK, Shah RP, Sim KH, Wan Ahmad WA, Alexanderson Rosas E, Alcocer Gamba MA, Alvarez Lopez H, Bayram Llamas E, Beltran Ochoa JJ, Benavides Gonzalez MA, Cardona Muñoz EG, Cervantes Escárcega JL, Chávez Michel J, Chuquiure Valenzuela E, Cigarroa López JA, Cruz Alvarado JE, De La Peña Topete GD, De Los Ríos Ibarra MO, Esturau Santaló RM, Feliciano-Ruiz G, García Lara H, Gomez-León Mandujano A, Hinojosa Pineda PA, Illescas Diaz JJ, Jerjes Sánchez Diaz C, Kusulas Zeron C, Leiva Pons JL, Lepe Montoya L, Magaña Serrano JA, Meaney Mendiolea E, Ortiz Medina JG, Pavia Lopez AA, Petersen Aranguren F, Ruiz Ruiz V, Solache Ortiz G, Villeda Espinosa E, Virgen Carrillo LR, Zuñiga Sedano JG, van Gilst WH, Jukema JW, Alings AM, Amoroso G, Bartels GL, Bokern MJ, Bruning TA, Cozijnsen L, de Graaf JJ, de Melker E, de Nooijer C, de Swart JB, den Hartog FR, Hamraoui K, Hermans WR, Hoedemaker G, Huizenga A, Ilmer B, Jukema JW, Klomps HC, Kragten JA, Ladyjanskaia GA, Lok DJ, Louwerenburg HW, Milhous JG, Nierop PR, Pieterse MG, Plomp J, Portegies MC, Ronner E, Terpstra WF, Troquay RP, van de Wetering ML, van den Berg BJ, van der Meer P, van der Zwaan C, van Geel PP, van Haelst PL, van Hessen MW, van 't Hof AW, van Wijk LM, Wardeh AJ, Werner HA, Westendorp IC, Willems FF, Zwart PA, Atar D, Munk P, Ronnevik P, Sirnes PA, Sy R, Atilano A, Ferrolino A, Rosas N, Sevilla MR, Topacio G, Rynkiewicz A, Adamus J, Andrzejak R, Baska J, Biedrzycka M, 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Zharinov O, Zhelesniy V, Zhurba S, Kuster F, Areco Geymonat D, Delorenzi Tusso MA, Hiriart JC, Pizzano N, Vega Rebufello G, Pham NV, Chau NH, Dang VP, Do QH, Nguyen VM, Nguyen TH, Nguyen LV, Nguyen QT, Vo TN, Vu DB.

Abstract

BACKGROUND:

An elevated heart rate is an established marker of cardiovascular risk. Previous analyses have suggested that ivabradine, a heart-rate-reducing agent, may improve outcomes in patients with stable coronary artery disease, left ventricular dysfunction, and a heart rate of 70 beats per minute or more.

METHODS:

We conducted a randomized, double-blind, placebo-controlled trial of ivabradine, added to standard background therapy, in 19,102 patients who had both stable coronary artery disease without clinical heart failure and a heart rate of 70 beats per minute or more (including 12,049 patients with activity-limiting angina [class ≥II on the Canadian Cardiovascular Society scale, which ranges from I to IV, with higher classes indicating greater limitations on physical activity owing to angina]). We randomly assigned patients to placebo or ivabradine, at a dose of up to 10 mg twice daily, with the dose adjusted to achieve a target heart rate of 55 to 60 beats per minute. The primary end point was a composite of death from cardiovascular causes or nonfatal myocardial infarction.

RESULTS:

At 3 months, the mean (±SD) heart rate of the patients was 60.7±9.0 beats per minute in the ivabradine group versus 70.6±10.1 beats per minute in the placebo group. After a median follow-up of 27.8 months, there was no significant difference between the ivabradine group and the placebo group in the incidence of the primary end point (6.8% and 6.4%, respectively; hazard ratio, 1.08; 95% confidence interval, 0.96 to 1.20; P=0.20), nor were there significant differences in the incidences of death from cardiovascular causes and nonfatal myocardial infarction. Ivabradine was associated with an increase in the incidence of the primary end point among patients with activity-limiting angina but not among those without activity-limiting angina (P=0.02 for interaction). The incidence of bradycardia was higher with ivabradine than with placebo (18.0% vs. 2.3%, P<0.001).

CONCLUSIONS:

Among patients who had stable coronary artery disease without clinical heart failure, the addition of ivabradine to standard background therapy to reduce the heart rate did not improve outcomes. (Funded by Servier; SIGNIFY Current Controlled Trials number, ISRCTN61576291.).

PMID:
25176136
[PubMed - indexed for MEDLINE]
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